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New treatment option for Hypertension
Official title Novel Setup Algorithm for Cardiac Neuromodulation Therapy
ClinicalTrials.gov ID: NCT05719454
What this study is testing
- What it's testing
- After meeting all inclusion/exclusion criteria, subjects on standard pacing with the Moderato® or Moderato Plus Implantable Pulse Generator (IPG) will be subjected to two set-up sessions for the CNT algorithm: at week 4 and at week 6 post implant. At the end of these visits, subjects will undergo a 24 ambulatory blood pressure recording after which CNT will be automatically turned OFF and standard pacing will resume.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject is ≥ 18 years of age
- Subject requires implantation or replacement of a dual chamber pacemaker or requires an upgrade from a single chamber to a dual chamber pacemaker.
- Subject has stable (for prior 1 month) hypertension treatment with 1, 2 or 3 antihypertensive drugs, which is planned to be maintained without...
- Subject has an office systolic blood pressure (oSBP) ≥140 and \<180 mmHg
- At 4 weeks from device implant, subject has an average 24-Hour ambulatory systolic blood pressure (aSBP) ≥130 mmHg and \<170 mmHg and an office blood...
You likely can't join if
- 1\. Subject has a known secondary cause of HTN (e.g. renal vascular disease, hyperthyroidism, hyperaldosterone and pheochromocytoma)
- Subject has permanent atrial fibrillation
- Subject has intermittent paroxysmal atrial fibrillation/flutter with significant burden (i.e., \>10% atrial fibrillation/flutter beats if available.
- Subject has an ejection fraction \<50%
- Subject has a drop of \> 15% (absolute) in ejection fraction from baseline to week 4
- Subject has symptoms of heart failure, NYHA Class II or greater
See the full eligibility criteria
- Subject is ≥ 18 years of age
- Subject requires implantation or replacement of a dual chamber pacemaker or requires an upgrade from a single chamber to a dual chamber pacemaker.
- Subject has stable (for prior 1 month) hypertension treatment with 1, 2 or 3 antihypertensive drugs, which is planned to be maintained without changes for a period of at least 2 months post implant.
- Subject has an office systolic blood pressure (oSBP) ≥140 and \<180 mmHg
- At 4 weeks from device implant, subject has an average 24-Hour ambulatory systolic blood pressure (aSBP) ≥130 mmHg and \<170 mmHg and an office blood pressure (oSBP) ≥140 and \<180 mmHg.
- Subject is willing and able to comply with study visits and procedures
- Subject is willing to adhere to the prescribed baseline antihypertension medical regimen for the duration of the study.
- 1\. Subject has a known secondary cause of HTN (e.g. renal vascular disease, hyperthyroidism, hyperaldosterone and pheochromocytoma)
- Subject has permanent atrial fibrillation
- Subject has intermittent paroxysmal atrial fibrillation/flutter with significant burden (i.e., \>10% atrial fibrillation/flutter beats if available.
- Subject has an ejection fraction \<50%
- Subject has a drop of \> 15% (absolute) in ejection fraction from baseline to week 4
- Subject has symptoms of heart failure, NYHA Class II or greater
- Subject has mitral regurgitation ≥2+, aortic stenosis with valve area \<1.0 cm2 , or is expected to need a valve repair or replacement.
- Subject has a history of stroke or TIA within 12 months or any prior stroke with a residual neurological deficit (modified Rankin Score \>2+)
- Subject experienced myocardial infarction (MI) within 3 months prior to enrolment
- Subject had a cardiovascular treatment procedure or cardiovascular surgery within 6 months prior to enrolment
- Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness ≥15 mm
- Subject is on dialysis
- Subject has estimated glomerular filtration rate (GFR) \<30 ml/min/1.73m²
- Subject has significant (\>50% occlusion of left or right carotid artery) carotid artery stenosis
- Subject has a history of clinically significant untreated ventricular tachyarrhythmia or has experienced sudden cardiac arrest
- Subject has an active device-based treatment for hypertension
- Subject has an existing active cardiac device or neurostimulator (e.g., ICD, spinal cord stimulator)
- Subject has Type I Diabetes
- Subject is a member of a vulnerable population (e.g., prisoners, pregnant or lactating women, mentally disabled)
- Subject has the possibility of becoming pregnant during the conduct of the study and is not willing to use a means of contraception during the study
- Subject cannot or is unwilling to provide informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Prague, Czechia
- Budapest, Hungary
- Krakow, Poland
- Poznan, Poland
- Szczecin, Poland
- Warsaw, Poland
- Zabrze, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Prague, Czechia; Budapest, Hungary; Krakow, Poland; Poznan, Poland; Szczecin, Poland; Warsaw, Poland and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.